A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus (THEMIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by AstraZeneca
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: November 18, 2013
Last updated: November 2, 2015
Last verified: November 2015
The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Ticagrelor 60 mg
Drug: Ticagrelor placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor Twice Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients With Type 2 Diabetes Mellitus (THEMIS - Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus Patients Intervention Study)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke [ Time Frame: Up to 35 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevention of CV death. The efficacy variable is time from randomisation to death of CV cause [ Time Frame: Up to 35 months ] [ Designated as safety issue: No ]
  • Prevention of MI. The efficacy variable is time from randomisation to first occurrence of MI [ Time Frame: Up to 35 months ] [ Designated as safety issue: No ]
  • Prevention of ischaemic stroke. The efficacy variable is time from randomisation to first occurrence of ischaemic stroke [ Time Frame: Up to 35 months ] [ Designated as safety issue: No ]
  • Prevention of all-cause death. The efficacy variable is time from randomisation to death of any cause [ Time Frame: Up to 35 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 19000
Study Start Date: February 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor 60 mg
Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
Drug: Ticagrelor 60 mg
Ticagrelor 60 mg bd taken orally as tablets
Other Name: Brilinta/Brilique
Placebo Comparator: Ticagrelor placebo Drug: Ticagrelor placebo
Ticagrelor placebo bd taken orally as tablets

Detailed Description:
A multinational, randomised, double-blind, placebo-controlled phase IIIb trial to evaluate the effect of ticagrelor twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus

Ages Eligible for Study:   50 Years to 130 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose lowering medication since at least 6 months, and either documented coronary artery occlusive disease or previous revascularization of a coronary artery.

Key Exclusion Criteria:

History of myocardial infarction or any stroke; planned treatment with agents inhibiting blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary, cerebrovascular, or peripheral arterial revascularization; patients with known bleeding disorders and patients who need chronic oral anticoagulant therapy or chronic low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of bleeding from the gastrointestinal tract within the last 6 months or a major surgery within the last 30 days; patients with known severe liver disease or with kidney failure requiring dialysis

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991795

Contact: AstraZeneca Clinical Study Information Center, MD, PhD 1-877-240-9479 information.center@astrazeneca.com

  Show 1114 Study Locations
Sponsors and Collaborators
Principal Investigator: Philippe Gabriel Steg, MD Hôpital Bichat-Claude Bernard 46 Rue Henri Huchard, Paris
Principal Investigator: Deepak L. Bhatt, MD Brigham and Women's Hospital75 Francis Street, Boston
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01991795     History of Changes
Other Study ID Numbers: D513BC00001
Study First Received: November 18, 2013
Last Updated: November 2, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Coronary artery disease

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on November 27, 2015